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Enrolling by invitation NCT05534425

Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange

No phase Interventional Virus Infection, RNA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GenX intergenerational mentoring program.
Who it may be relevant to
Registry conditions: Virus Infection, RNA. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This randomized controlled trial will test whether a recently developed community-based intergenerational mentoring program known as Generation Xchange (GenX) can enhance antiviral resistance in older African-American women and men in a low-SES urban community. Additional studies will identify the biological processes that promote resistance to respiratory virus infections and viral disease in older African-American women and men.

Detailed description

This randomized controlled intervention trial (planned n=160) will test whether participation in the Generation Xchange (GenX) intergenerational mentoring program can reduces vulnerability to respiratory virus infections (COVID, influenzas, colds), increase antiviral immune activity (Type I interferon responses), and reduce inflammatory immune activity in older African-American women and men living in a socioeconomically disadvantaged urban community. Blood samples will also be collected to determine which biological factors are most important in protecting older African-Americans from respiratory virus infection, and which of those factors is affected by the GenX intervention.

Interventions

  • Behavioral GenX intergenerational mentoring program
    GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.

Primary outcome measures

  • Concentration of Type I interferon antiviral activity (bioassay International Units / mL) [Time frame: 10 months]
Secondary outcome measures (2)
  • Respiratory virus antibody concentration (WHO international units BAU/mL) [Time frame: 10 months]
  • Pro-inflammatory cytokine concentration (pg/mL) [Time frame: 10 months]

Eligibility criteria

Inclusion criteria

  • Participating in the GenX intergenerational mentoring program
  • All GenX mentors > 50 years of age are eligible to participate in this research
  • GenX program participation requires:
  • Reside in neighborhood of GenX schools (South-Central Los Angeles)
  • Pass basic literacy and cognitive function tests

Exclusion criteria

  • Any health condition that would put participant at risk by enrollment/participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • UCLA School of Medicine — Los Angeles

Publications

  • Seeman T, Merkin SS, Goldwater D, Cole SW. Intergenerational mentoring, eudaimonic well-being and gene regulation in older adults: A pilot study. Psychoneuroendocrinology. 2020 Jan;111:104468. doi: 10.1016/j.psyneuen.2019.104468. Epub 2019 Sep 27. PMID 31589939

Identifiers

NCT: NCT05534425 · 21-001388 · R01AG073053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗